Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.
Study Type
OBSERVATIONAL
Enrollment
327,624
Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
Dipeptidyl peptidase-4 (DPP-4) inhibitor
Steno Diabetes Center Copenhagen, Department of Clinical Epidemiology
Gentofte Municipality, Denmark
Helsinki University Hospital
Helsinki, Finland
University of Ulm, Institute for Epidemiology and medical biometry
Ulm, Germany
Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition
Number of participants with Hospitalization for Heart Failure (HHF), using broad + specific HHF definition. HHF - broad defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics). HHF - specific defined as a primary diagnosis associated with hospital admission. For HHF - broad + specific, HHF-specific definition was used unless only broad definition were available. However, for Japan South Korea and Taiwan, both definitions were available, but broad definition was used.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i
Number of Participants With Hospitalization for Heart Failure (HHF), Broad Definition
Reported is the number of participants with hospitalization for heart failure (HHF), using broad definition of HHF. HHF - broad is defined as any diagnosis associated with healthcare encounters, including hospitalizations and specialist outpatient and primary care encounters, or dispensation or any other record of the high-ceiling diuretics (loop diuretics).
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i
Number of Participants With Hospitalization for Heart Failure (HHF), Specific Definition
Reported is the number of participants with hospitalization for heart failure, using specific definition for HHF. HHF - specific defined as a primary diagnosis associated with hospital admission.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i
Number of Participants With All-cause Mortality (ACM)
Number of participants with all-cause mortality (ACM).
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
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Maccabi Healthcare Services
Tel Aviv, Israel
Gifu University
Gifu, Japan
Oslo University Hospital, Department of Clinical Lipidology
Oslo, Norway
Oslo University Hospital, Department of Cardiology
Oslo, Norway
Ajou University Hospital
Suwon, South Korea
Instituto de Investigación Sanitaria INCLIVA
Valencia, Spain
TFS Trial Form Support International AB
Lund, Sweden
...and 3 more locations
Number of Participants With Composite Outcome, Including Hospitalization for Heart Failure (HHF) and All Cause Mortality (ACM)
Number of participants with composite outcome, including hospitalization for heart failure (HHF) and all cause mortality (ACM).
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Composite Outcome, Including Myocardial Infraction (MI), Stroke and All Cause Mortality (ACM)
Number of participants with composite outcome, including myocardial infraction (MI), stroke and all cause mortality (ACM).
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Myocardial Infarction (MI)
Number of participants with myocardial infarction (MI).
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Stroke
Number of participants with stroke.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Cardiovascular Mortality (CM)
Number of participants with cardiovascular mortality (CM).
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Composite Outcome Including Hospitalization for Heart Failure (HHF) and Cardiovascular (CV) Mortality
Number of participants with composite outcome including hospitalization for heart failure (HHF) and cardiovascular (CV) mortality.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With 3-point Major Adverse Cardiovascular (CV) Events (MACE), Defined as a Composite Outcome Including Myocardial Infarction (MI), Stroke and Cardiovascular (CV) Mortality
Number of participants with 3-point major adverse cardiovascular (CV) events (MACE), defined as a composite outcome including myocardial infarction (MI), stroke and cardiovascular (CV) mortality.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Coronary Revascularization Procedure
Number of participants with coronary revascularization procedure.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With End-stage Renal Disease (ESRD)
Number of participants with end-stage renal disease (ESRD).
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Estimated Glomerular Filtration Rate (eGFR) Decline
Number of participants with estimated glomerular filtration rate (eGFR) decline.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Progression From Normoalbuminuria to Micro- or Macroalbuminuria
Number of participants with progression from normoalbuminuria to micro- or macroalbuminuria.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Composite Outcome Including eGFR Decline and Progression to Micro- or Macroalbuminuria
Number of participants with composite outcome including Estimated glomerular filtration rate (eGFR) decline and progression to micro- or macroalbuminuria.
Time frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i.
Number of Participants With Bone Fracture
Number of participants with bone fracture. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i.
Time frame: From index date until end of follow-up, up to 67 months.
Number of Participants With Diabetic Ketoacidosis
Number of participants with diabetic ketoacidosis. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i
Time frame: From index date until end of follow-up, up to 67 months.
Number of Participants With Severe Hypoglycemia
Number of participants with severe hypoglycemia. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i.
Time frame: From index date until end of follow-up, up to 67 months.
Number of Participants With Lower-limb Amputation
Number of participants with lower-limb amputation. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i.
Time frame: From index date until end of follow-up, up to 67 months.
Number of Participants With Acute Kidney Injury Requiring Dialysis
Number of participants with acute kidney injury requiring dialysis. Data for this endpoint was only collected and analyzed for the matched cohort of empagliflozin/DPP-4i.
Time frame: From index date until end of follow-up, up to 67 months.
Healthcare Resource Utilization (HCRU): Number of Any Medical Visit
HCRU data were collected from seven of the 11 participating countries including Finland, Japan, South Korea, Norway, Spain, Sweden, and Taiwan. Outcomes captured as HCRU include emergency room visits, first inpatient stay, all-cause hospital admissions and outpatient healthcare visits. HCRU outcomes were investigated for the matched cohort of empagliflozin/DPP-4 only. Due to possibly huge differences in healthcare systems and local practices, HCRU outcomes were presented descriptively by country as per prespecified analysis plan. For arms with 0 patients analyzed, no data was collected for the specific outcome in this country.
Time frame: From index date until end of follow-up, up to 67 months.
Healthcare Resource Utilization (HCRU): Number of Any Prescription
HCRU data were collected from seven of the 11 participating countries including Finland, Japan, South Korea, Norway, Spain, Sweden, and Taiwan. Outcomes captured as HCRU include pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. HCRU outcomes were investigated for the matched cohort of empagliflozin/DPP-4 only. Due to possibly huge differences in healthcare systems and local practices, HCRU outcomes were presented descriptively by country as per prespecified analysis plan. For arms with 0 patients analyzed, no data was collected for the specific outcome in this country.
Time frame: From index date until end of follow-up, up to 67 months.
Total Healthcare Costs - Finland, Norway, Sweden
Total healthcare cost include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare costs for Finland, Norway and Sweden are reported in Euro per year. Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan.
Time frame: From index date until end of follow-up, up to 67 months.
Total Healthcare Cost - Japan
Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare cost for Japan are reported in Japanese Yen (JPY) per year. Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan.
Time frame: From index date until end of follow-up, up to 67 months.
Total Healthcare Cost - South Korea
Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare costs for South Korea are reported in 1000 Korean Won (KRW) per year. Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan.
Time frame: From index date until end of follow-up, up to 67 months.
Total Healthcare Cost - Taiwan
Total healthcare costs include costs for emergency room visits, first inpatient stay, all-cause hospital admissions, outpatient healthcare visits and pharmacy dispensations/prescriptions of different antidiabetic drugs, different drugs and prescriptions. Total healthcare cost for Taiwan are reported in United States Dollar (USD) per year. Due to possible huge differences in healthcare systems, cost of care outcomes are presented by country as prespecified in the analysis plan.
Time frame: From index date until end of follow-up, up to 67 months.